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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)  Food and Drug Administration (FDA) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.